What are the responsibilities and job description for the Quality Assurance Specialist position at Harba Solutions Inc.?
Role Overview
This position is a senior-level Quality Assurance role supporting aseptic manufacturing operations, with a primary emphasis on fill/primary processing activities. The immediate business need is to strengthen QA coverage within fill operations while maintaining flexibility to support other areas as needed. The successful candidate will bring strong independent decision-making skills and contribute to balancing team coverage across manufacturing and inspection activities.
The team is structured to promote clear ownership of functional areas while encouraging cross-training where appropriate. Adding an experienced QA professional with deep fill expertise will enhance operational continuity and reduce reliance on manual inspection coverage.
Core Responsibilities
- Provide QA oversight for aseptic fill and primary manufacturing operations
- Review manufacturing activities for compliance with cGMP and GDP requirements
- Support batch execution, real-time documentation review, and issue resolution
- Independently assess quality events, determine impact, and escalate or pause operations when necessary
- Author and support deviations, investigations, and related documentation
- Collaborate with Manufacturing, Inspection, Packaging, and Quality teams to ensure compliant and efficient operations
- Support document lifecycle activities including revisions, updates, and approvals
- Contribute to audit readiness and inspection support activities
Required Qualifications (Must-Have Experience)
- Prior QA experience supporting aseptic fill or primary manufacturing processes
- Experience working in regulated GMP environments
- Strong understanding of GMP and GDP principles
- Experience authoring or managing deviations
- Demonstrated ability to work autonomously with limited direct oversight
- Proven judgment in making quality decisions, including stopping or escalating production activities when required
Preferred Experience
- Exposure to automated inspection systems
- Experience supporting packaging operations, including complex configurations
- Familiarity with impact assessments and quality risk evaluation
- Experience with controlled document updates and revisions
- Working knowledge of root cause analysis methodologies (e.g., Fishbone, 6M, similar tools)
Level Expectations
This role is intended for candidates operating at a Senior Associate to Senior QA Specialist level.
This role is not suitable for:
- Entry-level QA professionals
- Candidates transitioning directly from operator roles without prior QA experience
- Individuals requiring extensive daily supervision
Experience Benchmarks
- Senior Associate: Demonstrates growing independence, authors deviations, supports document updates, and applies basic RCA tools
- QA Specialist: Possesses deep functional expertise in a core area (fill, inspection, or packaging) and operates with high autonomy
- Senior QA Specialist (Ideal): Serves as an informal team lead, manages complex quality issues, leads investigations and document revisions, and provides coverage in the absence of supervision